TRW & Co · Competition, Regulatory & Investigations
Life Sciences and Healthcare Lawyers in London
Life sciences lawyers in London guide pharmaceutical, biotech, medtech and healthcare businesses through regulation, market access and deals. 2026 brought major change: new clinical trials regulations took effect in April, medical device rules are being rebuilt, and a US-UK agreement raised NICE's cost-effectiveness threshold. Getting the regulatory route right early protects both timelines and value.
Key pointSince 28 April 2026, UK clinical trials must be publicly registered and results summaries published within twelve months of the trial ending, so publication, confidentiality and patent filing plans now need to be coordinated from the protocol stage.
At a glance
Clinical trials reformed
The amended clinical trials regulations came into force on 28 April 2026, with combined review, a notification scheme for lower-risk trials and new transparency duties.
Devices post-market rules
Strengthened post-market surveillance requirements for medical devices have applied in Great Britain since 16 June 2025, with pre-market reform following.
UK-wide licensing
Since 1 January 2025 the MHRA licenses medicines across the whole UK, and packs must carry a “UK Only” label under the Windsor Framework.
NICE threshold raised
After the April 2026 US-UK agreement, NICE's standard threshold rose to £25,000–£35,000 per QALY and the VPAG rate was capped at 15%.
Promotion is tightly controlled
Prescription-only medicines cannot be advertised to the public, and promotion to professionals is governed by the Human Medicines Regulations and ABPI Code.
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What life sciences and healthcare law covers in the UK
Life sciences lawyers in London advise the companies that discover, test, make, sell and pay for medicines, medical devices, diagnostics and health services. The work runs from a clinical trial authorisation to a marketing authorisation, from a distribution agreement to an NHS contract, and from a licensing deal for a patent to a regulator's inspection. Few sectors combine so much regulation with so much commercial value riding on timing.
The sector is broad. It includes pharmaceutical and biotech companies, medtech and diagnostics businesses, contract research and manufacturing organisations, digital health and AI developers, private healthcare providers, care operators and the investors and lenders behind them. Each faces its own regulator and rulebook, but they share common questions: can we put this product on the UK market, how will the NHS pay for it, and what must we do once it is in use?
The UK regime has changed substantially since Brexit and continues to move. New clinical trials regulations took effect in April 2026, the medical devices framework is being rebuilt in stages, Northern Ireland now sits inside UK-wide medicines licensing, and the pricing environment shifted after the 2026 US-UK pharmaceutical agreement. This page explains where things stand and how to plan around them.
Regulators and the legal framework
Life sciences lawyers in London start by working out which regulator and which instrument governs a product or service. The answer is not always obvious. Software can be a medical device, a food supplement can become a medicine through its claims, and a clinic may need registration as well as product approvals.
| Area | Main legislation or code | Regulator or body |
|---|---|---|
| Medicines | Human Medicines Regulations 2012; Medicines and Medical Devices Act 2021 | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Clinical trials | Medicines for Human Use (Clinical Trials) Regulations, as amended with effect from 28 April 2026 | MHRA and the Health Research Authority with research ethics committees |
| Medical devices and diagnostics | Medical Devices Regulations 2002, as amended | MHRA; UK approved bodies |
| Health technology assessment and pricing | NICE methods; voluntary scheme (VPAG) or statutory scheme | NICE in England; Scottish Medicines Consortium in Scotland; Department of Health and Social Care |
| Promotion to health professionals | Human Medicines Regulations 2012, Part 14; ABPI Code of Practice | MHRA; Prescription Medicines Code of Practice Authority (PMCPA) |
| Health and care services | Health and Social Care Act 2008 and the regulated activities regulations | Care Quality Commission (CQC) in England |
| Human tissue and fertility | Human Tissue Act 2004; Human Fertilisation and Embryology Act 1990 | Human Tissue Authority; HFEA |
The core medicines rules are in the Human Medicines Regulations 2012, which cover marketing authorisations, manufacturing and wholesale dealing licences, pharmacovigilance, labelling and advertising. The MHRA regulates medicines and devices across the UK, subject to the Northern Ireland arrangements discussed below.
Getting a medicine to market
A medicine needs a marketing authorisation before it can be sold or supplied in the UK. Applicants can use a full national application, or reliance routes such as the MHRA's International Recognition Procedure, which allows the agency to take account of approvals by specified reference regulators. Choosing the route is a strategic decision: it affects timing, data packages and how the UK launch fits a global plan. Life sciences lawyers in London usually map the UK route alongside the EU and US plans so that the data package and timetable work for all three.
Since 1 January 2025, the Windsor Framework arrangements for medicines have applied. The MHRA licenses medicines on a UK-wide basis, packs must carry a "UK Only" label, and the EU Falsified Medicines Directive safety features no longer apply in the UK. Companies that previously ran separate Great Britain and Northern Ireland supply chains have had to revisit licensing, labelling and packaging.
Licences across the supply chain
Manufacturers need a manufacturer's licence, importers and distributors need a wholesale dealer's licence, and each must have named responsible individuals, such as a qualified person or responsible person. Marketing authorisation holders must operate a pharmacovigilance system with a qualified person responsible for pharmacovigilance. Gaps in this licensing chain are a frequent finding in due diligence on life sciences businesses.
Clinical trials: the 2026 regulations
The updated UK clinical trials regulations came into force on 28 April 2026, after a twelve-month implementation period. They were made by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
Three changes matter most to sponsors. First, combined review of the regulatory and ethics applications is now written into law. Second, a notification scheme offers a faster route for certain lower-risk trials and modifications. Third, there are new transparency duties: trials must be registered on a public registry, a summary of results must be published within twelve months of the end of the trial, and participants must be offered a plain-language summary of results.
Sponsors should update clinical trial agreements, site contracts and data sharing terms to reflect the new duties, and check that publication obligations sit comfortably with confidentiality and patent filing strategies. Life sciences lawyers in London increasingly negotiate these agreements alongside the regulatory submission, rather than afterwards.
Medical devices, diagnostics and software
The Medical Devices Regulations 2002 remain the base of the GB regime, but the MHRA is reforming it in stages. New post-market surveillance requirements came into force on 16 June 2025. They clarify manufacturers' surveillance obligations, strengthen serious incident reporting and require periodic review of post-market data.
Pre-market reform is next. The MHRA published draft Medical Devices (Amendment) Regulations 2026 in May 2026, including an international reliance pathway for certain devices already approved in Australia, Canada or the United States. As at mid-2026 the regulations were expected to be made towards the end of the year, with key provisions taking effect around six months later. The MHRA also consulted between February and April 2026 on recognising CE-marked devices in Great Britain indefinitely. The MHRA implementation page tracks progress.
Software and AI raise their own classification questions. Whether a digital tool is a medical device depends on its intended purpose, so the wording of product claims, labelling and marketing can decide the regulatory route. Our artificial intelligence team advises on the overlap with wider AI governance.
In medtech and digital health, the words used to describe a product often decide how it is regulated. Settle the intended purpose before marketing copy is written, not after.
Pricing, reimbursement and the NHS
Regulatory approval does not guarantee NHS use. In England, NICE appraises clinical and cost-effectiveness, and its recommendations drive funding decisions. Scotland has its own process through the Scottish Medicines Consortium, and Wales and Northern Ireland have their own arrangements, so launch plans should treat each nation separately.
The US-UK pharmaceutical agreement announced on 2 April 2026 changed several parameters. NICE's standard cost-effectiveness threshold rose from £20,000–£30,000 to £25,000–£35,000 per quality-adjusted life year, the VPAG repayment rate was capped at 15% while the scheme remains in force, and UK pharmaceutical exports to the US became tariff-free for at least three years. Work on a replacement for VPAG is under way. Companies should revisit UK launch sequencing and evidence strategies in light of these changes.
Selling to the NHS also engages public procurement law. The Procurement Act 2023 governs most NHS purchasing of goods, while many clinical healthcare services in England are arranged under the Health Care Services (Provider Selection Regime) Regulations 2023. Our public procurement page explains how to bid and challenge decisions.
Promotion, interactions with professionals and anti-bribery
Prescription-only medicines cannot be advertised to the public. Promotion to health professionals is regulated by Part 14 of the Human Medicines Regulations 2012 and, for most companies, by the ABPI Code of Practice, administered by the PMCPA. The Code covers promotional claims, certification of materials, hospitality, payments to health professionals and disclosure of transfers of value.
Run every advisory board, consultancy and sponsorship arrangement through one approval process that records the legitimate need, the selection criteria for the health professionals involved and how fair market value was set. When a PMCPA complaint or bribery question arises, that file is the first thing a regulator or investigator will ask to see.
The Bribery Act 2010 sits behind these rules. Consultancy fees, advisory boards, sponsorship of meetings and grants to institutions all need a documented legitimate purpose and fair market value. Our anti-bribery and corruption team advises on adequate procedures for life sciences businesses operating across several countries.
Health data
Health data is special category data under the UK GDPR, so processing for research, product development or AI training needs a lawful basis and an additional condition, plus attention to the common law duty of confidentiality and NHS data access rules. The Data (Use and Access) Act 2025 adjusted the research provisions. See our data protection page for more.
A practical route from development to launch
Life sciences lawyers in London see the same sequencing problems repeatedly: products classified late, patents filed after publication, and supply partners signed before regulatory responsibilities are agreed. The steps below avoid the most common of them.
- Confirm classification. Decide whether the product is a medicine, device, in vitro diagnostic, combination product, cosmetic or food, and document the intended purpose.
- Secure the IP position. File patents before publication, check freedom to operate and plan supplementary protection and data exclusivity.
- Plan the evidence. Design trials or clinical investigations that meet MHRA requirements and generate the comparative data NICE and other bodies will need.
- Contract the supply chain. Put manufacturing, quality and distribution agreements in place with licensed partners and clear responsibility for pharmacovigilance or vigilance.
- Choose the regulatory route. Select the national, reliance or recognition pathway, and in devices the conformity assessment route, that fits the global launch plan.
- Prepare market access. Engage early with NICE or other appraisal bodies and model pricing under the current voluntary or statutory scheme.
- Launch compliantly. Certify promotional materials, train field teams, and set up adverse event reporting and post-market surveillance from day one.
Documents and evidence to assemble
Whether preparing for an inspection, a financing round or an acquisition, life sciences businesses are judged on their documents. Investors and buyers expect a clean regulatory file. Keep current:
- marketing authorisations, licences, certificates and registrations, with the named responsible individuals;
- quality management system documents, inspection reports and corrective action records;
- pharmacovigilance or vigilance system descriptions and safety databases;
- clinical trial approvals, protocols, agreements and registry entries;
- patent families, licences in and out, and records of inventorship and assignment;
- certified promotional materials and records of payments to health professionals;
- data protection impact assessments and data sharing agreements for health data.
Life sciences lawyers in London acting on investments treat gaps in this file as valuation and warranty issues, not housekeeping. Our mergers and acquisitions team runs regulatory due diligence on life sciences targets using this list as a starting point.
Risks and common mistakes
Making medicinal claims for a non-medicinal product
A product presented as treating or preventing disease can be classified as a medicine by presentation, whatever its ingredients. Supplements, cosmetics and wellness apps regularly cross this line through website copy, social media posts or influencer content. The consequence can be enforcement by the MHRA and the need to withdraw or relabel stock. Review claims against the classification rules before launch, and train marketing teams to recognise the line.
Assuming EU approvals carry over automatically
After Brexit, an EU approval is not a UK approval. Reliance routes can speed things up, and Great Britain currently continues to recognise CE-marked devices under transitional arrangements, but each has conditions and deadlines. The Windsor Framework added further changes for Northern Ireland. Build the UK route into the regulatory plan from the outset rather than treating it as an afterthought once EU approval is secured.
Weak control of partners and distributors
Marketing authorisation holders and device manufacturers remain responsible for safety reporting and product quality even when partners carry out the work. Distribution and licensing agreements that do not allocate pharmacovigilance, recall and complaint handling clearly create regulatory risk and disputes when something goes wrong. Quality agreements should sit alongside commercial terms, and audit rights should be used, not just written.
Publishing before protecting
Academic culture and new trial transparency duties both push towards early disclosure. Publishing data, presenting at a conference or registering a trial in detail before patent filings are made can destroy novelty. Coordinate publication plans, trial registry entries and patent filings, and make sure collaboration agreements with universities and hospitals give the company time to file before results are released.
Treating NHS data access as routine
Access to NHS patient data for research or product development involves several gatekeepers and legal tests. Assuming that pseudonymised data falls outside data protection law, or that a hospital partner can share data on request, is a common error. Map the data flows, identify the lawful basis and confidentiality position, and agree terms that reflect the controllers' obligations before any data moves.
The cross-border angle: Bangladesh, the EU, the Gulf and Asia
Bangladesh has a substantial domestic pharmaceutical industry that supplies most of its own market and exports to many countries. Its manufacturers have benefited from the flexibility given to least developed countries on pharmaceutical patents, so the country's scheduled graduation from least developed country status is an important issue for licensing and investment strategies. Medicines in Bangladesh are regulated by the Directorate General of Drug Administration.
For a UK company, the Bangladesh connection usually arises in three ways: contract manufacturing or sourcing of generics and active ingredients, licensing UK-developed products into South Asia, and investment by UK or diaspora investors into Bangladeshi healthcare. Each needs English law contracts that work with Bangladeshi regulatory approvals, foreign exchange rules and enforcement realities. TRW & Co's Dhaka, Chattogram and Sylhet offices advise on the Bangladesh side.
The EU remains the UK's closest regulatory comparator, and many companies run UK and EU programmes in parallel. Gulf states, Singapore and China each run their own reliance and registration systems, and TRW & Co's offices in Dubai, Singapore and China can coordinate local counsel. Inbound investment into UK life sciences may also need clearance under the National Security and Investment Act 2021 where sensitive areas such as synthetic biology are involved, as explained on our foreign investment and NSIA page.
How our life sciences lawyers in London help
We advise companies, founders, investors and healthcare providers on regulatory, commercial and transactional questions, and coordinate across our international offices where a matter involves Bangladesh, the Gulf or Asia.
Regulatory strategy
Classification, licensing and route-to-market advice for medicines, devices and digital health, including the Windsor Framework and the 2026 clinical trials and devices reforms.
Commercial agreements
Clinical trial, manufacturing, quality, supply, distribution and licensing agreements that allocate regulatory responsibility clearly and stand up when something goes wrong.
Compliance programmes
ABPI Code and Bribery Act compliance, interactions with health professionals, promotional review processes and responses to PMCPA complaints.
Transactions and investment
Regulatory due diligence, licensing deals, collaborations, financings and acquisitions, including NSIA assessments for inbound investment.
Healthcare providers
CQC registration, NHS contracts and procurement, and the governance and data questions that private healthcare and care operators face.
Disputes and investigations
Commercial disputes, regulatory investigations and procurement challenges, instructing specialist counsel where advocacy in the higher courts is required.
Checklist for decision-makers
- Is the classification of each product documented and consistent with how we market it?
- Have our trial agreements and processes been updated for the regulations in force since 28 April 2026?
- Do we rely on CE marking in Great Britain, and what is our plan as the devices regime changes?
- Are our packs and licences aligned with UK-wide licensing under the Windsor Framework?
- Has our UK launch and pricing strategy been revisited after the 2026 changes to the NICE threshold and VPAG?
- Do our partner agreements allocate pharmacovigilance, recalls and quality responsibilities clearly?
- Are patent filings coordinated with publications and trial registry entries?
- Do we have a lawful and documented basis for every use of health data?
Life sciences lawyers in London can help most when involved early in a development or deal. To discuss your position, contact our London office at Holborn Gate, 330 High Holborn, London WC1V 7QH, or browse our full list of practice areas.
Frequently asked questions
01Who regulates medicines and medical devices in the UK?
The Medicines and Healthcare products Regulatory Agency regulates both, under the Human Medicines Regulations 2012 and the Medical Devices Regulations 2002 respectively. Clinical trials also involve the Health Research Authority and research ethics committees. Promotion of prescription medicines is policed by the MHRA and, through the ABPI Code, by the PMCPA. Health and care services in England are registered and inspected by the Care Quality Commission, with separate bodies in Scotland, Wales and Northern Ireland.
02What changed for clinical trials in April 2026?
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 came into force on 28 April 2026. Combined regulatory and ethics review is now part of the law, a notification scheme speeds up certain lower-risk trials and modifications, and new transparency rules require trials to be publicly registered, results summaries to be published within twelve months of the trial ending, and participants to be offered a lay summary of results. Sponsors should update agreements and internal processes accordingly.
03Can we still sell CE-marked medical devices in Great Britain?
Currently yes, under transitional arrangements that allow CE-marked devices to be placed on the GB market for a period. The MHRA consulted in 2026 on making that recognition indefinite and has published draft pre-market regulations that include a reliance pathway for devices approved in Australia, Canada or the United States. Northern Ireland follows different rules under the Windsor Framework. Check the latest MHRA position for your device class before relying on CE marking long term.
04How does the Windsor Framework affect medicines in Northern Ireland?
From 1 January 2025, the MHRA authorises medicines on a UK-wide basis, so companies generally no longer need separate Great Britain and Northern Ireland licences. Packs supplied in the UK must carry a “UK Only” label, and the EU Falsified Medicines Directive safety features no longer apply in the UK. Companies need to make sure their licences, labelling and packaging reflect these arrangements.
05What did the 2026 US-UK pharmaceutical agreement change?
Announced on 2 April 2026, it raised NICE's standard cost-effectiveness threshold from £20,000–£30,000 to £25,000–£35,000 per quality-adjusted life year, capped the VPAG repayment rate at 15% while the scheme remains in force, and made UK pharmaceutical exports to the US tariff-free for at least three years. A replacement for the voluntary scheme is being designed. Launch, pricing and evidence plans for the UK should be reviewed in light of these changes.
06Can we advertise a prescription medicine on social media?
Not to the public. Prescription-only medicines may only be promoted to health professionals and other appropriate audiences, and social media posts, influencer content and sponsored articles can all amount to advertising. Promotional material aimed at professionals must comply with Part 14 of the Human Medicines Regulations 2012 and, for most companies, the ABPI Code, including certification. Disease awareness campaigns are possible but must not promote a particular medicine.
07Does investment in a UK biotech need government clearance?
It may. The National Security and Investment Act 2021 requires mandatory notification of certain acquisitions of entities active in sensitive sectors, which include synthetic biology, and the government can call in other deals. Investors and companies should assess the target's activities early, because completing a notifiable acquisition without approval makes it void. Merger control and sector-specific rules may also apply depending on the deal.
Sources and official materials
- Medicines and Healthcare products Regulatory Agency — UK medicines and devices regulator
- The Human Medicines Regulations 2012 — Core medicines legislation
- HRA: clinical trial regulations reform — 2026 clinical trials changes
- Implementation of the future regulation of medical devices — MHRA devices reform timeline
- The Medical Devices Regulations 2002 — GB devices legislation
- PMCPA: the ABPI Code — Industry code on promotion
- National Institute for Health and Care Excellence — Health technology appraisal
- Care Quality Commission — Health and care services regulator
General information only, current as at 21 October 2026. It is not legal advice and does not create a solicitor–client relationship. It reflects the law of England and Wales unless stated otherwise; Scotland and Northern Ireland have separate legal systems, and the law changes frequently. Check current official sources and take advice on the facts of your matter.